Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-06 @ 12:22 PM
Study NCT ID:
NCT02024204
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2013-12-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joan.reibman@nyumc.org', 'phone': '212-263-6479', 'title': 'Joan Reibman, MD', 'organization': 'NYU Langone'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Uncontrolled LRS', 'description': 'Patients who have uncontrolled lower respiratory symptoms (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Forced Oscillation Technique (FOT) Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'OG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'classes': [{'title': 'Pre BD R5', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '5.7'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '5.7'}]}]}, {'title': 'Pre BD R5-20', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.5'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.4'}]}]}, {'title': 'Post BD R5', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '5.3'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '5.7'}]}]}, {'title': 'Post BD R5-20', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.2'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).', 'unitOfMeasure': 'resonant frequency', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Spirometry Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'OG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'classes': [{'title': 'Pre-BD FEV1/FVC', 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '72.4', 'upperLimit': '82.4'}, {'value': '81.2', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '83.4'}]}]}, {'title': 'Post-BD FEV1/FVC', 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '82.2'}, {'value': '77.7', 'groupId': 'OG001', 'lowerLimit': '75.4', 'upperLimit': '81.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'Measured pre/post BD (bronchodilator). Reported as ratio: %FEV1(Liters)/FVC(Liters).\n\nFEV1 = forced expiratory volume at 1 second FVC = forced vital capacity', 'unitOfMeasure': '% FEV1(Liters)/FVC(Liters)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'OG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'To test whether bronchial Hyperreactivity (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'OG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'measured by laryngoscopic visualization at rest or after provocation with various odors or exercise.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total IgE (Immunoglobulin E) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'OG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '135'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 1', 'description': 'IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total EoS (Eosinophil) Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'OG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '.10', 'groupId': 'OG000', 'lowerLimit': '.10', 'upperLimit': '.20'}, {'value': '.10', 'groupId': 'OG001', 'lowerLimit': '.10', 'upperLimit': '.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 1', 'description': 'EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.', 'unitOfMeasure': 'eosiniphils *10^9/Liter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Levels of Fractional Exhaled Nitric Oxide (FeNO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'OG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '22.2'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '13.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': "Measured using a portable device that measures the level of nitric oxide in parts per billion (PPB) in the air slowly exhaled out of the patient's lungs.", 'unitOfMeasure': 'parts per billion (ppb)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Voice Handicap Index 10 (VHI-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'OG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '17'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'Voice Handicap Index 10 is a measure of laryngeal dysfunction or hypersensitivity to capture the "overall" state of voice handicap. The normative value for this instrument is 2.83, with a score \\> 11 considered abnormal. There are 10 statements that are scored between 0 and 4 (0= never, 4= always). The total range is 0-40, where 40 is highest level of dysfunction.', 'unitOfMeasure': 'score on VHI-10 scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'OG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '42.5'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '18.2', 'upperLimit': '29.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'For rhinosinusitis symptoms, the ICSD scoring system was used, with a likert scale of 1-10 for each symptom (total range of scale = 1-60, with higher scores reflecting more symptoms).', 'unitOfMeasure': 'score on ICSD scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Leicester Cough Questionnaire (LCQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'OG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '15.4'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '20.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': 'For rhinosinusitis symptoms, the Leicester Cough Questionnaire (LCQ) was used - a cough-specific health status questionnaire that assesses the physical, psychological, and social domains of cough. The LCQ is made up of 19 items; the total score range is 3-21; a higher score is associated with better health.', 'unitOfMeasure': 'score on LCQ scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'FG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Visit 1 Uncontrolled LRS', 'description': 'Patients who have uncontrolled LRS (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.\n\nFluticasone propionate 230mcg for 3 Months\n\nSalmeterol 21mcg for 3 Months'}, {'id': 'BG001', 'title': 'Visit 1 Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.\n\nCurrent Treatment or no treatment: Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '62'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '62'}, {'value': '56.5', 'groupId': 'BG002', 'lowerLimit': '47.8', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'NH-White', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'NH-Black', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Asian and Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-12-31', 'size': 419637, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-12T15:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2013-12-18', 'resultsFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2013-12-26', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-12', 'studyFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Oscillation Technique (FOT) Measures', 'timeFrame': 'Week 12', 'description': 'Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).'}, {'measure': 'Spirometry Measures', 'timeFrame': 'Week 12', 'description': 'Measured pre/post BD (bronchodilator). Reported as ratio: %FEV1(Liters)/FVC(Liters).\n\nFEV1 = forced expiratory volume at 1 second FVC = forced vital capacity'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)', 'timeFrame': 'Week 12', 'description': 'To test whether bronchial Hyperreactivity (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms.'}, {'measure': 'Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)', 'timeFrame': 'Week 12', 'description': 'measured by laryngoscopic visualization at rest or after provocation with various odors or exercise.'}, {'measure': 'Total IgE (Immunoglobulin E) Levels', 'timeFrame': 'Week 1', 'description': 'IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.'}, {'measure': 'Total EoS (Eosinophil) Counts', 'timeFrame': 'Week 1', 'description': 'EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.'}, {'measure': 'Levels of Fractional Exhaled Nitric Oxide (FeNO)', 'timeFrame': 'Week 12', 'description': "Measured using a portable device that measures the level of nitric oxide in parts per billion (PPB) in the air slowly exhaled out of the patient's lungs."}, {'measure': 'Score on Voice Handicap Index 10 (VHI-10)', 'timeFrame': 'Week 12', 'description': 'Voice Handicap Index 10 is a measure of laryngeal dysfunction or hypersensitivity to capture the "overall" state of voice handicap. The normative value for this instrument is 2.83, with a score \\> 11 considered abnormal. There are 10 statements that are scored between 0 and 4 (0= never, 4= always). The total range is 0-40, where 40 is highest level of dysfunction.'}, {'measure': 'Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)', 'timeFrame': 'Week 12', 'description': 'For rhinosinusitis symptoms, the ICSD scoring system was used, with a likert scale of 1-10 for each symptom (total range of scale = 1-60, with higher scores reflecting more symptoms).'}, {'measure': 'Score on Leicester Cough Questionnaire (LCQ)', 'timeFrame': 'Week 12', 'description': 'For rhinosinusitis symptoms, the Leicester Cough Questionnaire (LCQ) was used - a cough-specific health status questionnaire that assesses the physical, psychological, and social domains of cough. The LCQ is made up of 19 items; the total score range is 3-21; a higher score is associated with better health.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['World Trade Center Disaster', 'Environmental Exposure', 'Respiratory Physiology', 'Inflammation', 'Gastrointestinal Diseases', 'Sinus Symptoms', 'PTSD', 'Anxiety', 'Depression', 'Hypersensitivity', 'Spirometry', 'Oscillometry'], 'conditions': ['Lung Diseases', 'Medication Compliance']}, 'referencesModule': {'references': [{'pmid': '17983880', 'type': 'BACKGROUND', 'citation': 'National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.'}, {'pmid': '19365288', 'type': 'BACKGROUND', 'citation': 'Reibman J, Liu M, Cheng Q, Liautaud S, Rogers L, Lau S, Berger KI, Goldring RM, Marmor M, Fernandez-Beros ME, Tonorezos ES, Caplan-Shaw CE, Gonzalez J, Filner J, Walter D, Kyng K, Rom WN. Characteristics of a residential and working community with diverse exposure to World Trade Center dust, gas, and fumes. J Occup Environ Med. 2009 May;51(5):534-41. doi: 10.1097/JOM.0b013e3181a0365b.'}, {'pmid': '21642248', 'type': 'BACKGROUND', 'citation': 'Friedman SM, Maslow CB, Reibman J, Pillai PS, Goldring RM, Farfel MR, Stellman SD, Berger KI. Case-control study of lung function in World Trade Center Health Registry area residents and workers. Am J Respir Crit Care Med. 2011 Sep 1;184(5):582-9. doi: 10.1164/rccm.201011-1909OC.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand why patients in the World Trade Center program have continuing breathing problems. This study will improve investigators understanding of breathing problems among individuals with World Trade Center exposure by allowing them to review and monitor medication use, lung function, and examine other conditions that can contribute to problems with breathing. The findings from the study will help investigators understand why some people have persistent lower respiratory symptoms (breathing problems) after their exposure to World Trade Center dust and fumes, and may help guide better management and treatment of these symptoms.', 'detailedDescription': 'Investigators will conduct a clinical study with aggressive treatment for lower respiratory symptoms in patients in the World Trade Center Environmental Health Center. Patients in the WTC EHC with uncontrolled LRS at visit 1 will be identified and placed on high-dose inhaled corticosteroids and long-acting beta agonists for three months. Adherence will be assessed at monthly visits. Patients will perform spirometry and oscillometry at baseline and after 3 months of treatment. They will also be assessed for markers of airway inflammation, bronchial hyperresponsiveness and co-morbid conditions including depression,anxiety,post-traumatic stress disorder, gastroesophageal reflux, paradoxical vocal cord motion and rhinosinusitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years and \\<75\n* Meet criteria for World Trade Center Environmental Health Center enrollment\n* Onset of lower respiratory symptoms after 9/11/01\n* Persistent lower respiratory symptoms (\\> 2 times per week)\n* Pre-bronchodilator forced expiratory volume in one second (FEV1) within normal limits\n* \\< 5 pack-year tobacco history\n* Not current smoker\n* Asthma Control Test Score ≤ 19\n* Normal chest x-ray\n\nExclusion Criteria:\n\n* Age \\< 18 years and ≥75\n* Lower respiratory symptoms or asthma history pre 9/11/01\n* No persistent lower respiratory symptoms\n* pre-bronchodilator FEV1 within normal limits\n* \\> 5 pack year tobacco\n* Current smoker\n* Abnormal Chest X-Ray or parenchymal changes on high resolution computed tomography\n* Uncontrolled major chronic illness (diabetes mellitus, congestive heart failure, cancer)\n* History of significant non-World Trade Center occupational or environmental exposure\n* Allergy to study drug\n* Pregnancy, lactation or plans to become pregnant\n* Chronic oral corticosteroid use\n* High risk of fatal or near-fatal asthma within the previous 2 years\n* Other lung disease (Idiopathic pulmonary fibrosis,sarcoid, etc.)'}, 'identificationModule': {'nctId': 'NCT02024204', 'briefTitle': 'Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program', 'orgStudyIdInfo': {'id': '13-00448'}, 'secondaryIdInfos': [{'id': '1U01OH010404-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1U01OH010404-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Uncontrolled LRS', 'description': 'Patients who have uncontrolled lower respiratory symptoms (ACT \\< 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.', 'interventionNames': ['Drug: Fluticasone propionate 230mcg for 3 Months', 'Drug: Salmeterol 21mcg for 3 Months']}, {'type': 'OTHER', 'label': 'Controlled LRS', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.', 'interventionNames': ['Drug: Current Treatment or no treatment']}], 'interventions': [{'name': 'Fluticasone propionate 230mcg for 3 Months', 'type': 'DRUG', 'otherNames': ['Advair HFA'], 'armGroupLabels': ['Uncontrolled LRS']}, {'name': 'Current Treatment or no treatment', 'type': 'DRUG', 'description': 'Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.', 'armGroupLabels': ['Controlled LRS']}, {'name': 'Salmeterol 21mcg for 3 Months', 'type': 'DRUG', 'armGroupLabels': ['Uncontrolled LRS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joan Reibman, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Occupational Safety and Health (NIOSH/CDC)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}